Glycopyrronium Bromide 200 micrograms/ml Solution for Injection
1. Name of the medicinal product
Glycopyrronium Bromide 200 micrograms /ml Solution for Injection
2. Qualitative and quantitative composition
Each ml of injection contains 200 micrograms (0.2mg) of Glycopyrronium Bromide.
Each 3ml of injection contains 600 micrograms (0.6mg) of Glycopyrronium Bromide.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection
Clear and colourless solution
pH 2.0-3.0
4. Clinical particulars
4.1 Therapeutic indications
To protect against the peripheral muscarinic actions of anticholinesterases such as neostigmine, used to reverse residual neuromuscular blockade produced by non-depolarising muscle relaxants.
As a pre-operative antimuscarinic agent to reduce salivary tracheobronchial and pharyngeal secretions.
As a pre-operative or intra-operative antimuscarinic to attenuate or prevent intra-operative bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes.
4.2 Posology and method of administration
Glycopyrronium Bromide Injection is a sterile solution for intravenous or intramuscular administration.
Premedication
Adults, adolescents over 12 years old and elderly patients:
200 to 400 micrograms (0.2mg to 0.4mg) intravenously or intramuscularly before the induction of anaesthesia. Alternatively, a dose of 4 to 5 micrograms/kg (0.004 to 0.005mg/kg) up to a maximum of 400 micrograms (0.4mg) may be used. Larger doses may result in profound and prolonged antisialogogue effect which may be unpleasant for the patient.
When Glycopyrronium Bromide Injection is administered intramuscularly it should be used 30-60 minutes before the induction of anaesthesia
Paediatric population (1 month to 12 years of age):
4 to 8 micrograms/kg (0.004 to 0.008mg/kg) up to a maximum of 200 micrograms (0.2mg) intravenously or intramuscularly before the induction of anaesthesia. Larger doses may result in profound and prolonged antisialogogue effect which may be unpleasant for the patient.
Intra-operative use
Adults, adolescents over 12 years old and elderly patients:
A single dose of 200 to 400 micrograms (0.2 to 0.4mg) by intravenous injection should be used. Alternatively, a single dose of 4 to 5 micrograms/kg (0.004 to 0.005mg/kg) up to a maximum of 400 micrograms (0.4mg) may be used. This dose may be repeated if necessary.
Paediatric population (1 month to 12 years of age):
A single dose of 200 micrograms (0.2mg) by intravenous injection should be used. Alternatively, a single dose of 4 to 8 micrograms/kg by intravenous injection (0.004 to 0.008mg/kg) up to a maximum of 200 micrograms (0.2mg) may be used. This dose may be repeated if necessary.
Reversal of residual non-depolarising neuromuscular block
Adults, adolescents over 12 years old and elderly patients:
200 micrograms (0.2mg) intravenously per 1000 micrograms (1mg) of neostigmine alternatively, a dose of 10 to 15 micrograms/kg (0.01 to 0.015mg/kg) intravenously with 50 micrograms/kg (0.05mg/kg) neostigmine or equivalent dose of pyridostigmine. Glycopyrronium Bromide Injection may be administered simultaneously from the same syringe with the anticholinesterase; as there are greater cardiovascular stability results from this method of administration.
